ST. LOUIS • Severe mistakes happen, even at hospitals that receive high marks from federal health officials. And consumers usually never learn the details of these errors.
In a very small percentage of surgeries, doctors operate on the wrong knee or breast, and in rare cases amputate the wrong body part.
But when a neurosurgeon operates on the wrong side of a person’s brain, as happened last month at an SSM Health Care hospital in the St. Louis area, it is a unique event and a medical mistake of the highest order.
A wrong-site surgery on the brain — of which only about one a year has been documented since the mid-1960s — can rob a person of cognition, emotional strength and ability to interact with others, as well as traumatize and scar a patient’s family, caregivers and the medical professionals who made the error.
According to national experts, it is usually a signal that the institution’s quality control processes — systems that are designed to safeguard the lives and limbs of patients — are insufficient.
In a public apology issued Tuesday, Chris Howard, president and chief executive of SSM Health Care-St. Louis, admitted that one of the health system’s neurosurgeons operated on the wrong side of a 53-year-old woman’s skull and brain.
“This was a breakdown in our procedures, and it absolutely should never have happened,” he said.
The case of Regina Turner, a former paralegal who lived in St. Ann, is a significant crisis for not only St. Clare Health Center in Fenton, where the brain surgery took place on April 4, but also for Creve Coeur-based SSM Health Care, a Catholic nonprofit health system that runs 18 hospitals in Missouri and three other states.
The case also points to weaknesses in federal and Missouri law that leave patients as consumers with a limited view of hospital performance. Unless litigation about a hospital error is reported by news media, Missourians rarely learn about these surgical mistakes. And without this data, consumers have less information to help them make choices about medical care.
Missouri is among the minority of states that do not require hospitals to report serious errors and also among those states that do not operate a public database of information about these occurrences. Such events normally remain hidden from public scrutiny.
As a result of publicity about SSM’s botched brain surgery, the Post-Dispatch has found evidence of a life-threatening medication error that occurred in July 2011 in connection with the neurosurgery of a different patient at St. Clare. No lawsuit was filed, but the hospital admitted its error and waived the patient’s surgery and hospitalization bills.
SSM has been caught in a whirlwind of media coverage, state and federal investigations, litigation and the task of determining exactly what happened and how the health system’s processes can be fixed so this kind of event never happens again.
In an interview, Howard said SSM was conducting a “root-cause analysis” to determine all the causes of Turner’s wrong-site surgery and it intends to share its findings with the Joint Commission, an independent nonprofit organization that accredits about 20,000 health facilities nationwide, as well as with the Missouri Center for Patient Safety.
The state Department of Health and Senior Services and the federal Centers for Medicare and Medicaid Services are also investigating the April 4 event.
Most operating rooms follow the “universal protocol,” an extensive checklist of safety procedures for surgeons and operating teams that was developed by the Joint Commission and became effective in 2004 for all accredited hospitals and outpatient surgery centers. It includes detailed checks and a “time-out” to make certain that a surgeon operates on the correct patient at the correct site and with the correct procedure, including unambiguously marking the correct spot.
Stressing that the Turner case is in litigation, Howard would not say specifically what errors occurred on April 4.
“We have an excellent idea of what happened,” he said, “and the public should be assured we have instituted safeguards to make certain it doesn’t happen again.”
Dr. Kevin Johnson, medical director for SSM Health Care-St. Louis, said the health system had advised its operating teams throughout its network of the error, reviewed quality processes including the “universal protocol,” and asked staff to identify further measures for improvement.
SSM officials would not disclose whether Turner’s neurosurgeon and members of the operating team had been disciplined.
‘A HIGH-PERFORMING INSTITUTION’
By most outward measures, St. Clare Health Center has been performing well since its opening in 2009.
The 154-bed hospital has fairly high marks on “core measures” that gauge a hospital’s general performance on the “hospital compare” website overseen by the federal Centers for Medicare and Medicaid Services:
• St. Clare’s treatment of heart attack, congestive heart failure, pneumonia and surgical care rank in the 78th percentile of hospitals nationwide.
• Serious complications and 30-day mortality and readmission rates are “no different than the national average.”
A third-party survey indicates that overall patient satisfaction is fairly high at St. Clare, with 83 percent of patients saying that they would “definitely recommend” the hospital to their family and friends. Similarly, a third-party survey last year of nearly 400 health care systems nationwide found 83-percentile employee satisfaction at St. Clare.
In the past three years, the Joint Commission has investigated seven complaints at St. Clare, but none of the situations — regarding patient treatment and care, infection prevention and control, human resources, and leadership issues — was found to be serious enough to warrant an “improvement requirement” measure.
“St. Clare is a superior hospital by almost every clinical measure and satisfaction measure reportable,” SSM’s Howard said. “It is a high-performing institution.”
But those statistics tell only part of the story.
Hospitals are not required by law to publicly report “never events” — those devastating events such as wrong-site, wrong-person surgeries and other serious mistakes that, with proper vigilance, should never occur.
In Missouri, hospitals also are not required by law to publicly report “sentinel events” involving the serious physical or psychological injury of a patient. State and federal health agencies at times investigate serious hospital errors, but generally do not make their findings public.
Some hospitals voluntarily report their “sentinel events” to the Joint Commission, whose staff investigates these incidents and works with hospitals to develop better safeguards. But the lack of mandatory public reporting requirements leaves consumers with a less-than-comprehensive view of hospital performance.
On Wednesday, a Joint Commission spokesman said it had no record of the April 4 surgery at St. Clare — and thus had not been aware of the incident nor was conducting an investigation.
“We encourage organizations to report it to us. The more timely, the better,” said Bret Coons, the spokesman.
Coons said the voluntary reporting of such incidents helps to quickly focus a hospital’s attention on understanding all the factors that contributed to a serious error and correcting deficiencies so the mistake won’t happen again.
But he cautioned that, similar to airline industry accidents, even the best quality control systems are vulnerable.
“There’s no silver bullet” for a wrong-site surgery, Coons said. “It’s very critical everything goes right at every step of the process. One minor thing can go wrong and it can snowball.”
A report by the Joint Commission’s Center for Transforming Healthcare cited national estimates that each year there may be more than 200 “wrong patient, wrong procedure, wrong site and wrong side surgeries.”
“They are typically rare events, but we have gotten a number of these events across the state — either wrong site, wrong patient, or wrong procedure — reported to us,” said Becky Miller, executive director of the Missouri Center for Patient Safety in Jefferson City. “Every single case is different. ... It’s not like comparing mistakes that happen on an assembly line.”
Miller said that it’s difficult for hospitals to voluntarily report serious medical errors. “Our legal system doesn’t encourage or allow providers to openly discuss this kind of information,” she said.
By federal law, nonprofit independent organizations such as the Center for Patient Safety provide a way for hospitals to privately share data about serious errors, “near-misses” and unsafe conditions. The center identifies statewide trends and particular trouble spots, and it works with hospitals to upgrade their safeguards.
Helen Burstin, senior vice president for performance measures at the nonprofit National Quality Forum in Washington, described wrong-site surgeries as “an important opportunity for hospitals to share with each other and learn from these issues.”
But she cautioned that it would be difficult to discern a hospital’s rate of serious errors because institutions handle different patient volumes and patient populations with varying conditions as well as provide medical services of various levels of complexity.
“We know that some of the best institutions are more readily willing to report,” Burstin said. “The willingness to report demonstrates a willingness to learn.”
MIXED TRACK RECORD
Regina Turner, a former paralegal, now requires around-the-clock care and cannot speak intelligibly, according to her attorney, Alvin Wolff Jr. of Clayton.
The suit on her behalf accuses SSM Health Care-St. Louis and the neurosurgeon — who is identified by the initials “A.L.” — with carelessness and negligence that led to the wrong-site brain surgery.
Wolff has confirmed that Dr. Armond Levy operated on his client. Levy had no comment, said Kristen Johnson, an SSM spokeswoman.
Levy, 46, appears to have a satisfactory track record in what experts view as one of medicine’s most litigious specialties.
Two malpractice lawsuits have been filed against Levy since his license to practice medicine was granted in 1996, and legal experts say that is probably par for the course. There is no public record of any disciplinary action taken against him by the state medical board.
Still, the family of at least one of Levy’s former patients recalls a questionable incident at St. Clare that did not end up at the courthouse.
Mairian King of Ballwin says her husband, John F. King, now 71, was treated by Levy after suffering a stroke. Levy operated on King in February and July of 2011.
After surgery to replace his cranial plate on July 22, 2011, she said, her husband almost bled to death because he had been mistakenly given the wrong medication.
Their son, Brandon King, of Ballwin, said Levy emerged from the operating room and told him and his brother, John Jr., that the operation had gone well but there was “a lot of blood.” An hour or so later, Brandon King said, his father was being given large amounts of blood to save his life.
Levy and an anesthesiologist summoned the brothers to a conference room. According to Brandon King, the doctors said they had reviewed King’s surgical tray and found that he had received Heparin — a blood thinner — rather than Hespan, a drug that was supposed to reduce bleeding during and after the surgery.
King survived the ordeal, but his hospitalization was lengthened. He is in a nursing home. His wife said the incident did not result in lawsuit.
Brandon King complained to the hospital about his father’s treatment, and St. Clare sent two letters to the Kings — apologizing to the family and waiving “any personal financial responsibility you may have to SSM for your hospitalization.”
In a letter to the Kings on Aug. 5, 2011, hospital claims coordinator Deanne Jockish confirmed that the anesthetist involved in the surgery had inadvertently administered the wrong medicine. “We believe the medication event occurred due to the similarity of the names and labels of the two drugs,” Jockish wrote.
She said the hospital was “exploring the possibility of both changing the labeling of the two drugs to make them more distinguishable and having medication scanning in the OR” to prevent future errors.
In a letter on Aug. 9, 2011, to the patient, the hospital’s patient services specialist, Jim Connolly, wrote that the hospital’s then-chief medical officer and interim president, Dr. Tim Pratt, had investigated the incident. “All events such as this are thoroughly explored in an internal quality assurance process,” he wrote.
The Joint Commission’s Coons said Thursday that the staff was unaware of the July 22 medication error at St. Clare — and thus had not investigated the incident.
“We have multiple layers of safety measures in place to prevent medication errors, and we are vigilant in those efforts,” said SSM’s Howard, adding that in the past four years St. Clare had had only one medication error that harmed a patient. He would not specify when that event occurred.
Citing a federal patient privacy law, he declined to discuss the King case.
“He almost bled to death,” Mairian King said of her husband’s close call. “There’s a problem in their operating room, and they need to fix it before they kill somebody. It makes me mad they are continuing to make mistakes like that.”